Surgical Instrument with Linear and Purse String Suture Staples

This application is a continuation of U.S. application Ser. No. 18/271,432 filed 7 Jul. 2023, which is a National Stage of International Application No. PCT/US2021/065308 filed 28 Dec. 2021, which claims the benefit of U.S. Provisional Application Ser. No. 63/134,961, filed 8 Jan. 2021, the entire disclosure of which is incorporated herein by reference for all purposes.

Minimally invasive medical techniques are intended to reduce the amount of extraneous tissue that is damaged during diagnostic or surgical procedures, thereby reducing patient recovery time, discomfort, and deleterious side effects. One effect of minimally invasive surgery, for example, is reduced post-operative hospital recovery times. The average hospital stay for a standard open surgery is typically significantly longer than the average stay for an analogous minimally invasive surgery (MIS). Thus, increased use of MIS could save millions of dollars in hospital costs each year. While many of the surgeries performed each year in the United States could potentially be performed in a minimally invasive manner, only a portion of the current surgeries uses these advantageous techniques due to limitations in minimally invasive surgical instruments and the additional surgical training involved in mastering them.

Improved surgical instruments such as tissue access, navigation, dissection and sealing instruments have enabled MIS to redefine the field of surgery. These instruments allow surgeries and diagnostic procedures to be performed with reduced trauma to the patient. A common form of minimally invasive surgery is endoscopy, and a common form of endoscopy is laparoscopy, which is minimally invasive inspection and surgery inside the abdominal cavity. In standard laparoscopic surgery, a patient's abdomen is insufflated with gas, and cannula sleeves are passed through small (approximately one-half inch or less) incisions to provide entry ports for laparoscopic instruments.

Laparoscopic surgical instruments generally include an endoscope (e.g., laparoscope) for viewing the surgical field and tools for working at the surgical site. The working tools are typically similar to those used in conventional (open) surgery, except that the working end or end effector of each tool is separated from its handle by an extension tube (also known as, e.g., an instrument shaft or a main shaft). The end effector can include, for example, a clamp, grasper, scissor, stapler, cautery tool, linear cutter, or needle holder.

To perform surgical procedures, the surgeon passes working tools through cannula sleeves to an internal surgical site and manipulates them from outside the abdomen. The surgeon views the procedure from a monitor that displays an image of the surgical site taken from the endoscope. Similar endoscopic techniques are employed in, for example, arthroscopy, retroperitoneoscopy, pelviscopy, nephroscopy, cystoscopy, cisternoscopy, sinoscopy, hysteroscopy, urethroscopy, and the like.

Minimally invasive telesurgical robotic systems are being developed to increase a surgeon's dexterity when working on an internal surgical site, as well as to allow a surgeon to operate on a patient from a remote location (outside the sterile field). In a telesurgery system, the surgeon is often provided with an image of the surgical site at a control console. While viewing a three dimensional image of the surgical site on a suitable viewer or display, the surgeon performs the surgical procedures on the patient by manipulating master input or control devices of the control console, which in turn control motion of the servo-mechanically operated slave instruments.

The servomechanism used for telesurgery will often accept input from two master controllers (one for each of the surgeon's hands) and may include two or more robotic arms on each of which a surgical instrument is mounted. Operative communication between master controllers and associated robotic arm and instrument assemblies is typically achieved through a control system. The control system typically includes at least one processor that relays input commands from the master controllers to the associated robotic arm and instrument assemblies and back from the instrument and arm assemblies to the associated master controllers in the case of, for example, force feedback or the like. One example of a robotic surgical system is the DA VINCI™ system commercialized by Intuitive Surgical, Inc. of Sunnyvale, California.

A variety of structural arrangements have been used to support the surgical instrument at the surgical site during robotic surgery. The driven linkage or “slave” is often called a robotic surgical manipulator, and exemplary linkage arrangements for use as a robotic surgical manipulator during minimally invasive robotic surgery are described in U.S. Pat. No. 7,594,912 (filed Sep. 30, 2004), U.S. Pat. No. 6,758,843 (filed Apr. 26, 2002), U.S. Pat. No. 6,246,200 (filed Aug. 3, 1999), and U.S. Pat. No. 5,800,423 (filed Jul. 20, 1995), the full disclosures of which are incorporated herein by reference in their entirety for all purposes. These linkages often manipulate an instrument holder to which an instrument having a shaft is mounted. Such a manipulator structure can include a parallelogram linkage portion that generates motion of the instrument holder that is limited to rotation about a pitch axis that intersects a remote center of manipulation located along the length of the instrument shaft. Such a manipulator structure can also include a yaw joint that generates motion of the instrument holder that is limited to rotation about a yaw axis that is perpendicular to the pitch axis and that also intersects the remote center of manipulation. By aligning the remote center of manipulation with the incision point to the internal surgical site (for example, with a trocar or cannula at an abdominal wall during laparoscopic surgery), an end effector of the surgical instrument can be positioned safely by moving the proximal end of the shaft using the manipulator linkage without imposing potentially hazardous forces against the abdominal wall. Alternative manipulator structures are described, for example, in U.S. Pat. No. 6,702,805 (filed Nov. 9, 2000), U.S. Pat. No. 6,676,669 (filed Jan. 16, 2002), U.S. Pat. No. 5,855,583 (filed Nov. 22, 1996), U.S. Pat. No. 5,808,665 (filed Sep. 9, 1996), U.S. Pat. No. 5,445,166 (filed Apr. 6, 1994), and U.S. Pat. No. 5,184,601 (filed Aug. 5, 1991), the full disclosures of which are incorporated herein by reference in their entirety for all purposes.

During the surgical procedure, the telesurgical system can provide mechanical actuation and control of a variety of surgical instruments or tools having end effectors that perform various functions for the surgeon, for example, holding or driving a needle, grasping a blood vessel, dissecting tissue, or the like, in response to manipulation of the master input devices. Manipulation and control of these end effectors is a particularly beneficial aspect of robotic surgical systems. Such mechanisms should be appropriately sized for use in a minimally invasive procedure and relatively simple in design to reduce possible points of failure. In addition, such mechanisms should provide an adequate range of motion to allow the end effector to be manipulated in a wide variety of positions.

Surgical anastomosis joins together two hollow organs, usually to restore continuity after resection, or less commonly to bypass an unresectable disease process. For example, during a lower anterior resection (LAR) procedure, a portion of the intestines near the rectum is removed. The surgeon typically applies a linear staple line across the bowel to seal the healthy portion of the bowel and to resect the tissue to be removed, leaving at least one linear staple line on the distal stump of the rectum. During the anastomosis, a circular stapler is advanced through the bowel and the two remaining ends of the bowel are drawn together so that they can be joined in an anastomosis with the circular stapler.

Unfortunately, there are often complications with this procedure because the linear staple line interacts with the circular stapler when the circular staple line crosses over the linear staple line to form the anastomosis. To resolve this problem, a purse string suture can be applied to the bowel to cinch the bowel and prevent or eliminate the linear and circular staple lines from crossing. The purse string suture is typically placed using a needle, staples or other suitable means for attaching the suture to the tissue. After attachment, the ends of the suture remain loose for pulling to contract or cinch close the bowel tissue.

One of the drawbacks with this procedure is that the purse-string suture is difficult to perform manually (i.e., hand-sewn) in a closed abdomen procedure. In addition, the purse string hoop is typically held down via a series of knots, which makes the purse string hoop non-compliant. If the purse string hoop is too tight, it will rupture when the either the spike or the anvil posts of the circular stapler enter the purse string hoop.

Another drawback with existing devices and procedures is that the distance between the linear stapler line and the transection plane (i.e., the line of dissection of the bowel) is limited by the geometry of the stapler device. In order to provide a successful interaction between the purse string suture and the circular stapler, a sufficient amount of tissue must be preserved between the purse string staples and the transection plane. This is known as a “tissue cuff”. Tissue cuff provides compliance within the purse string hoop. The more “tissue cuff” that can be achieved, the less likely there will be complications with the circular stapler. Tissue within the purse string hook makes it less likely that an interaction will occur. In addition, it provides confidence to the user that tissue will completely cover the staple zone of the circular stapler.

In minimally invasive surgical anastomosis procedures, it would be advantageous to provide surgical instruments and devices that enable faster, easier and more consistent purse string suture hoops to be applied to tissue, such as bowel tissue. In addition, it would be desirable to increase the tissue cuff between the purse string suture hoop and the transection plane to facilitate the user drawing the purse string hoop closed and to minimize complications with the circular stapler performing the anastomosis.

The following presents a simplified summary of the claimed subject matter in order to provide a basic understanding of some aspects of the claimed subject matter. This summary is not an extensive overview of the claimed subject matter. It is intended to neither identify key or critical elements of the claimed subject matter nor delineate the scope of the claimed subject matter. Its sole purpose is to present some concepts of the claimed subject matter in a simplified form as a prelude to the more detailed description that is presented later.

In one aspect, a surgical stapling instrument comprises an elongate shaft and an end effector coupled to the distal end of the shaft and comprising first and second jaws configured to move between open and closed positions. The instrument includes a first row of staples in each of the first and second jaws having a suture extending therethrough and a second row of staples in the second jaw on an opposite side of the longitudinal axis from the first row of staples. A drive member is configured to translate distally through the end effector to drive the first and second row of staples into tissue such that the suture is disposed between the first row of staples and the tissue. The instrument may further include a cutting element coupled to the drive member and configured to dissect tissue as the drive member translates distally through the first and second jaws.

The drive member is preferably configured to drive the first row of staples into tissue such that the suture, in combination with the staples, forms a purse string with the tissue. This is achieved by securing a suture to the outer surface of the tissue via staples that pinch the surface of the tissue.

Accordingly, surgical instruments disclosed herein can simultaneously transect tissue, apply a linear staple line along one side of the tissue dissection and apply a suture, such as a purse string suture, to the other side of the tissue dissection. These instruments are particularly useful for dissection of bowl tissue. For example, the tissue dissection allows for the two ends of the bowel to be separated for eventual removal of the resected specimen. The application of the linear staple line allows the user to close one end of the specimen to prevent content spillage. The application of a purse-string suture on the other end allows the user to cinch the bowel and prepare it for eventual anastomosis after the unwanted tissue has been removed. Performing all three of these functions with a single instrument makes the entire procedure faster, easier and more consistent for the user. In addition, it minimizes complications associated with crossing staple lines when used with an end-to-end circular stapler (e.g., during bowel resection procedures).

In certain embodiments, the distance between the purse string staples and the cutting element along the tissue contacting surfaces of the jaws is greater than a distance between the linear staples and the cutting element. This increases the amount of “tissue cuff” between the resection line and the purse string staples, thereby minimizing complications between the purse string staples and the circular stapler during the anastomosis.

In one such embodiment, the cutting element is disposed laterally from the longitudinal axis on an opposite side from the purse string suture staples. Thus, the distance between the cutting element and the purse string staples is increased, thereby increasing the size of the tissue cuff.

In another embodiment, the purse string staples in the first and second jaws are oriented at a transverse angle relative to the longitudinal axis of the shaft such that one of the staple legs of each staple is distal to the other staple leg. This configuration angles the purse string staples away from the transection line, thereby increasing the size of the tissue cuff.

In yet another embodiment, the first and second jaws each comprise an angled portion on their tissue contacting surfaces that extends downwardly from a first axis to a second axis. The first axis is closer to the upper portion of the shaft than the second axis. The angled portion of the tissue contacting surfaces extends downwardly from the cutting element towards the purse string staples. This creates a jog in the plane in which the tissue sits between the jaws of the device, thereby increasing the length of the tissue contacting surfaces between the cutting element and the purse string staples.

The surgical instruments may include one of the above embodiments, all of them, or any combination of them.

The first row of staples in the first jaw may be offset longitudinally from the first row of staples in the second jaw such that each staple in the first jaw is disposed between two staples in the second jaw in the longitudinal direction (and vice versa). This allows the staples in the first jaw to be positioned closer to the staples in the second jaw in the pre-fired position (i.e., before the staples are driven into tissue). Offsetting the staples in this manner provides more space in the jaws, thereby providing a more compact and maneuverable instrument.

The instrument may further comprise a cartridge removably coupled to the first and second jaws. The cartridge includes a shuttle configured to engage the first row of staples in the second jaw and the second row of staples as the drive member is translated distally through the first and second jaws. The shuttle engages the staples and drives them into tissue. The drive member may comprise a distal portion configured to engage the first row of staples in the first jaw as the drive member is translated distally through the first and second jaws. This distal portion may be integral with the drive member and is configured to drive the staples into tissue.

The drive member may comprise a main body and a lateral portion extending laterally outward from the main body. The lateral portion includes one or more distal inclined ramps configured for engaging the staples in the first jaw to drive them into tissue. The lateral portion may be integral with the drive member, which eliminates the requirement for a separate shuttle in the staple cartridge for actuating the row of staples in the first jaw. This creates more space in the suture cartridge, thereby allowing for the design of a more compact and maneuverable instrument.

The instrument may further comprise an actuation mechanism configured to translate the drive member distally through the end effector. The actuation mechanism may be coupled to a control device of a robotic telesurgical system that may, for example, allow for mechanical actuation and control of the surgical instrument to perform a variety of functions, such as closing the jaws, dissecting and stapling tissue, or the like, in response to manipulation of master input devices located remotely from the surgical instrument.

In another aspect, a surgical stapling instrument comprises an elongate shaft and an end effector coupled to the distal end of the shaft having first and second jaws configured to move between open and closed positions. The instrument includes a first row of staples in each of the first and second jaws with a suture extending therethrough. A suture holding member is disposed within the end effector such that at least one of the free ends of the suture is coupled to the suture holding member. A drive member is configured to translate distally through the first and second jaws to drive the first and second rows of staples into tissue such that the suture extends between the staples and the tissue.

The suture holding member allows the user to apply a purse string hoop around tissue without having to tie knots to hold the purse string hoop tight, thereby making the procedure easier, faster and more consistent than conventional procedures. In addition, the suture holding member provides some degree of compliance to the purse string hoop, such that the purse string has some “give” when the circular stapler spike and/or anvil post enters the purse string hoop. This minimizes or eliminates rupture of the purse string suture when the circular stapler is performing the anastomosis. In addition, the suture holding member allows the operator to loosen the purse string hoop, if desired.

In certain embodiments, the suture holding member may be configured such that both the first and second free ends of the suture extend therethrough. This allows the user to easily tighten down the purse string hoop simply by holding the suture holding member and pulling the frees ends of the suture.

In one such embodiment, the suture holding member comprises a tissue contacting surface and the suture extends through the suture holding member such that the first and second free ends extend substantially tangential to the tissue contacting surface. Thus, the suture extends through the suture holding member such that the first and second free ends extend away from the suture holding member in substantial opposite directions from each other. This minimizes the tension on the adjacent staples as the suture is tightened, i.e., the holding member acts as a passive pulley that absorbs at least some of force applied by the sutures as they are pulled and tightened.

In another such embodiment, the suture holding member comprises a tissue contacting surface and the suture extends through the suture holding member such that the first and second free ends extend substantially radially to the tissue contacting surface. Thus, the suture extends through the suture holding member such that the first and second free ends extend away from the suture holding member in substantial the same direction. This allows the user to tighten the purse string suture via a surgical “draw down” technique in which one hand holds the suture holding member down, while the other hand pulls both suture ends away from the holding member.

The suture holding member may have a tissue contacting surface, and a second surface opposite the tissue contacting surface. The suture holding member is disposed within the end effector such that the second surface faces a distal end of the end effector when the staples have been driven into the tissue. In this manner, the suture holding member will be facing the same direction that the instrument approached the tissue after the purse string hoop has been applied to the bowel. This improves visualization of the suture holding member and positions the suture holding member closer to the user, thereby allowing the user to immediately visualize the suture holding member after the purse string hoop has been applied to the tissue. This makes it easier to tighten down the suture holding member (e.g., without having to search for the suture holding member on the other side of the bowel).

The first and second jaws may each comprise a longitudinal channel for receiving a portion of the suture that is substantially parallel with the row of staples. The suture holding member is disposed proximal to the row of staples. The suture extends from the suture holding member distally through the row of staples in the first jaw, proximally through the channel in the first jaw, distally through the channel in the second jaw and then proximally through the row of staples in the second jaw such that the second free end is disposed proximally of the first row of staples. Thus, the suture forms a substantially U-shape in each of the first and second jaws, thereby allowing a user to apply the suture and suture holding member to tissue with the instrument such that the suture holding member is facing the instrument.

The suture may be coupled to the suture holding member and configured to release under a threshold level of tension. This allows the suture holding member to hold the suture when tightened down and generally manipulated, but would release under some level of tension. For example, as the circular stapler enters the purse string hoop and stretches it wider, the suture holding member will release if the tension level becomes sufficiently high to rupture the purse string hoop.

The suture holding member may comprise a compliant material, such as rubber or a similarly compliant material. The suture holding member may be designed with compliant features to allow such functionality. The suture may be woven through the suture holding member to create a friction fit between the suture and the holding member. This friction fit is strong enough to hold the suture holding member down against the tissue, but compliant enough to minimize or avoid rupture of the purse string hoop during the anastomosis.

The suture holding member may include one or more locking elements that provide a non-linear path for the suture either through the suture holding member, or as the suture exits the holding member. The locking elements are configured to hold the suture under a certain level of tension, while providing sufficient compliance to prevent rupture of the purse string hoop during the anastomosis.

The first and second ends of the suture may extend through openings in the suture holding member. The suture holding member is configured to hold the suture with friction, while allowing the suture to have some degree of movement relative to the suture holding member at a threshold force. In an exemplary embodiment, the suture has a length selected to allow the bowel to expand to its natural, unconstrained configuration with the free ends of the suture extending through the suture holding member. In one such embodiment, the free ends of the suture are coupled to each other (or designed as a loop such that there is no “free end”) to ensure that the suture does not withdraw through the suture holding member. This allows the bowel to expand while ensuring that the suture will remain in position around the bowel and secure within the suture holding member.

In another embodiment, a first free end of the suture is coupled to the suture holding member, and the suture holding member comprises an opening for receiving the second free end of the suture. The opening includes an enlarged region for passing the second free end of the suture therethrough, and a narrowed slot for securing the second free end of the suture to the suture holding member. This allows the user to feed the second free end of the suture into the opening, cinch the purse string hoop tight, and then draw the suture into the narrowed slot to secure the suture and keep the purse string hoop tight throughout the remainder of the procedure. In other embodiments, the suture holding member and/or the suture includes one or more features (e.g., directional barbs on the suture, zip ties, crimps or other locking elements on the suture holding member) that allow the suture to be easily fed or pulled therethrough in one direction, while resisting movement in the opposite direction.

It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the disclosure. Additional features of the disclosure will be set forth in part in the description which follows or may be learned by practice of the disclosure

Particular embodiments of the present surgical instruments are described hereinbelow with reference to the accompanying drawings; however, it is to be understood that the disclosed embodiments are merely exemplary of the disclosure and may be embodied in various forms. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present disclosure in virtually any appropriately detailed structure. Well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in any unnecessary detail. Like numbers in two or more figures represent the same or similar elements. Furthermore, elements and their associated aspects that are described in detail with reference to one embodiment may, whenever practical, be included in other embodiments in which they are not specifically shown or described. For example, if an element is described in detail with reference to one embodiment and is not described with reference to a second embodiment, the element may nevertheless be claimed as included in the second embodiment. Moreover, the depictions herein are for illustrative purposes only and do not necessarily reflect the actual shape, size, or dimensions of the system or illustrated components.

While the following is presented with respect to a surgical instrument for forming purse strings and linear staples, it should be understood that certain features of the presently described surgical instruments may be readily adapted for use in any type of surgical clamping, cutting, or sealing instruments. In addition the surgical clamping and cutting instrument may be a minimally invasive (e.g., laparoscopic) instrument or an instrument used for open surgery.

Additionally, the features of the presently described surgical stapling instruments may be readily adapted for use in surgical instruments that are activated using any technique within the purview of those skilled in the art, such as, for example, manually activated surgical instruments, powered surgical instruments (e.g., electro-mechanically powered instruments), robotic surgical instruments, and the like.

is a perspective view of an illustrative surgical instrumenthaving a backend mechanism, and an end effectorwith first and second jaws,mounted on an elongated shaft. Backend mechanismtypically provides a mechanical coupling between the drive tendons or cables of the instrument and motorized axes of the mechanical interface of a drive system. Further details of known backend mechanisms and surgical systems are described, for example, in U.S. Pat. Nos. 8,597,280, 7,048,745, and 10,016,244. Each of these patents is hereby incorporated by reference in its entirety.

Actuation mechanisms of surgical instrumentemploy drive cables that are used in conjunction with a system of motors and pulleys. Powered surgical systems, including robotic surgical systems that utilize drive cables connected to a system of motors and pulleys for various functions including opening and closing of jaws, as well as for movement and actuation of end effectors are well known. Further details of known drive cable surgical systems are described, for example, in U.S. Pat. Nos. 7,666,191 and 9,050,119 both of which are hereby incorporated by reference in their entireties.

illustrate the distal end portion of surgical instrument, including an end effectordefining a longitudinal axis X-X and having a first jaw, a second jaw, a lower cartridge, an upper cartridge, a clevisfor mounting jaws,to the instrument, and an articulation mechanism, such as wrist. First and second jaws,are configured to move from an open position () to a closed position (). In certain embodiments, second jawis a movable jaw configured to move from an open position to a closed position relative to first jaw. In other embodiments, first jawis a movable jaw configured to move between open and closed positions relative to second jaw. In still other embodiments, both jaws,are movable relative to each other. In the open position, fresh stapling cartridges,(sometimes referred to as reloads and shown more clearly in) can be loaded into jaws,and tissue may be positioned between the jaws,. In the closed position, jaws,cooperate to clamp, sever and staple tissue, as discussed in more detail below.

In certain embodiments, jaws,are attached to surgical instrumentvia a suitable coupling device, such as a clevis(see also). Clevisincludes an opening for receiving a pivot pindefining a pivot axis around which jawpivots. A more complete description of a suitable clevisfor use with the devices disclosed herein may be found in commonly-assigned, co-pending provisional patent application numbers: 62,783,444, filed Dec. 21, 2018; U.S. Pat. No. 62,783,481, filed Dec. 21, 2018; U.S. Pat. No. 62,783,460, filed Dec. 21, 2018; U.S. Pat. No. 62,747,912, filed Oct. 19, 2018; and U.S. Pat. No. 62,783,429, filed Dec. 21, 2018, the complete disclosures of which are hereby incorporated by reference in their entirety for all purposes. Of course, it will be recognized by those skilled in the art that other coupling mechanisms known by those skilled in the art may be used to attach the jaws,to shaftof surgical instrument.

Referring now to, lower cartridgeincludes an elongate body designed to fit within a cavityof lower jawsuch that lower cartridgeis removably coupled to jaw. Alternatively, the entire lower jawmay comprise the cartridge and cartridgewill be removably attached to a proximal portion of end effector. Lower cartridgeincludes first and second sides,at least partially separated by a center knife channel(see). Sidedefines a tissue contacting surfaceand includes staple retaining pocketsand sidedefines a tissue contacting surfaceand includes staple retaining pockets. Sidefurther includes suture retaining channels (not shown) formed therein for retaining a suture. In certain embodiments, tissue contacting surfaces,may further include protrusions (not shown) positioned about staple receiving pockets,. Protrusions help to further secure clamped tissue and to resist movement that might be induced from forces created by the severing and stapling of clamped tissue.

Sideof lower cartridgefurther includes a plurality of staple assemblies, each comprising one or more staplessupported on corresponding staple drivers or pushersprovided within staple receiving pockets. Staple receiving pocketsmay be cutouts that are substantially parallel to the longitudinal axis X-X of end effector, and similar in length to the desired size of staplesto be fired.

The staple assemblies may be designed to have one row of staples, two rows of staplesoriented parallel to each other along the longitudinal axis of end effector, or three or more rows of staples. In an exemplary embodiment, each staple assembly includes three staples oriented to form two linear rows of staples extending along sideof lower cartridge. The term “linear staple” generally means that the staples extend substantially parallel to the longitudinal axis X-X of the end effector such that a linear staple line is applied to the tissue along this axis. The staple assemblies are preferably arranged within the compartments such that staple pushersare situated near a bottom surface of lower cartridgeand stapleshave their legs facing a top surface of cartridge. For ease of reference, the top surface of cartridgefaces jaw(see).